Trial Outcomes & Findings for Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair (NCT NCT02084069)

NCT ID: NCT02084069

Last Updated: 2015-03-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 58 participants
• Primary outcome timeframe: Within 5 days after open cardiac valve repair
• Results posted on: 2015-03-04

Participant Flow

Participant milestones

Measure	Treatment Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery	Control Placebo
Overall Study STARTED	29	29
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

Baseline characteristics by cohort

Measure	Treatment n=29 Participants Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery	Control n=29 Participants Placebo	Total n=58 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	45 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 5 days after open cardiac valve repair

Outcome measures

Measure	Treatment n=29 Participants Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery	Control n=29 Participants Placebo
Atrial Fibrillation Incidence After Open Cardiac Valve Repair	6 participants	13 participants

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=29 participants at risk Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery	Control n=29 participants at risk Placebo
Blood and lymphatic system disorders Postoperative bleeding	3.4% 1/29 • Number of events 1	6.9% 2/29 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Yousef Rezaei

Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences

Phone: +989126231864

Email: yousefrezaei1986@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place